Small Cell Lung Cancer ( SCLC )NCT07905937
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
An observational study of Small Cell Lung Cancer ( SCLC ) and Brain Injury, run by Guizhou Medical University at 1 site in China.
Trial summary
The study aims to enroll the small cell lung cancer(SCLC) who meet the indications for prophylactic cranial irradiation (PCI): patients with limited-stage SCLC who have achieved complete or partial remission after first-line treatment, or patients with extensive-stage SCLC whose tumors are effectively controlled after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer ( SCLC ), Brain Injury
- What is being tested?
- PD-1 Inhibitor + Chemotherapy+PCI and chemotherapy+PCI
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Jun 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI).
Who may be able to join
- Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI): patients with limited-stage disease achieving complete response (CR) or partial response (PR) after first-line treatment; patients with extensive-stage disease achieving effective tumor control after systemic therapy, with no clear evidence of brain metastasis.
- Age 18-75 years, Karnofsky Performance Status (KPS) score ≥ 70.
- Estimated survival ≥ 6 months, with completion of at least 12 months of follow-up.
- No contraindications to radiotherapy, chemotherapy, or immunotherapy.
- Good compliance with the treatment protocol and follow-up, and provision of informed consent.
Who cannot join
- Patients with brain metastases, cerebral infarction, cerebral hemorrhage, sequelae of traumatic brain injury, or other primary brain diseases (e.g., Alzheimer's disease, multiple sclerosis) confirmed by MRI before enrollment.
- Patients who have previously received brain radiotherapy, brain surgery, or immunotherapy.
- Patients with psychiatric disorders or cognitive impairment (MMSE score < 26) unable to cooperate with follow-up assessments.
- Patients with a history of other malignancies prior to or concurrent with the current treatment.
- Severe cardiac, pulmonary, or renal disease, active autoimmune disease, or uncontrolled active infectious disease.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Affiliated Hospital of GuiZhou Medical University
Guiyang, Guizhou, 550004
Zhang Hao Project Liaison Officer, Ph.D, +86 0851-86814581, gmuzh21@gmail.com
About this study
Official title: A Prospective Cohort Observational Study of Brain Injury Induced by Whole-Brain Radiotherapy Combined With Immunotherapy
The study aims to enroll the small cell lung cancer(SCLC) who meet the indications for prophylactic cranial irradiation (PCI): patients with limited-stage SCLC who have achieved complete or partial remission after first-line treatment, or patients with extensive-stage SCLC whose tumors are effectively controlled after systemic therapy with no definitive evidence of brain metastases. Additional inclusion criteria are expected survival≥6 months, completion of at least 12 months of follow-up, and signed informed consent obtained before enrollment after explaining the study objectives and methods.The observation group consists of patients with extensive-stage SCLC receiving first-line chemotherapy combined with concurrent immunotherapy. After two cycles, patients with a confirmed response (CR, PR, or SD) undergo PCI. The control group consists of patients with limited-stage SCLC receiving standard concurrent chemoradiotherapy (systemic therapy plus thoracic radiotherapy). After two cycles of systemic therapy, those with a confirmed response undergo PCI.Starting from the completion of PCI, contrast-enhanced MRI of the brain (plain scan, contrast-enhanced scan, and DWI) and contrast-enhanced CT of the chest and whole abdomen are performed every three months. Treatment-related toxicity is evaluated using CTCAE v5.0. Cognitive function is assessed every three months using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). Venous blood samples are collected one day before radiotherapy and every three months thereafter to measure white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, liver function, renal function, electrolytes, and coagulation function; stool and urine tests are also performed. The data are analyzed to determine whether whole-brain radiotherapy combined with immunotherapy exacerbates neurological impairment.
- Conditions
- Small Cell Lung Cancer ( SCLC ), Brain Injury
- Being tested
- PD-1 Inhibitor + Chemotherapy+PCI, chemotherapy+PCI
- Medical subject headings
- Small Cell Lung Carcinoma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 Inhibitor + Chemotherapy+PCIDrug
The study was retrospective and did not use interventional protocols. The recommended first-line treatment for patients with extensive-stage small cell lung cancer is PD-1 inhibitor combined with chemotherapy. Under the condition that brain metastases have been excluded after effective drug therapy, prophylactic cranial irradiation (PCI) may be performed.
chemotherapy+PCIDrug
The study was retrospective and did not use interventional protocols. For patients with limited-stage small cell lung cancer, the recommended first-line treatment is platinum-based cytotoxic chemotherapy, and prophylactic cranial irradiation (PCI) may be administered after achieving a response to drug therapy.
| Study group | Role | What they receive |
|---|---|---|
| Observation Group | Extensive-stage small cell lung cancer Receives: Drug: PD-1 Inhibitor + Chemotherapy+PCI | |
| Control Group | Limited-stage small cell lung cancer Receives: Drug: chemotherapy+PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start30 Jun 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer ( SCLC )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905937
- Sponsor's protocol ID
- RIBI
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Observational Study of Brain Injury Induced by Whole-Brain Radiotherapy Combined With Immunotherapy
- ClinicalTrials.gov ID
- NCT07905937
- Acronym / sponsor ID
- RIBI
- Conditions
- Small Cell Lung Cancer ( SCLC ), Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to enroll the small cell lung cancer(SCLC) who meet the indications for prophylactic cranial irradiation (PCI): patients with limited-stage SCLC who have achieved complete or partial remission after first-line treatment, or patients with extensive-stage SCLC whose tumors are effectively controlled after systemic therapy with no definitive evidence of brain metastases. Additional inclusion criteria are expected survival≥6 months, completion of at least 12 months of follow-up, and signed informed consent obtained before enrollment after explaining the study objectives and methods.The observation group consists of patients with extensive-stage SCLC receiving first-line chemotherapy combined with concurrent immunotherapy. After two cycles, patients with a confirmed response (CR, PR, or SD) undergo PCI. The control group consists of patients with limited-stage SCLC receiving standard concurrent chemoradiotherapy (systemic therapy plus thoracic radiotherapy). After two cycles of systemic therapy, those with a confirmed response undergo PCI.Starting from the completion of PCI, contrast-enhanced MRI of the brain (plain scan, contrast-enhanced scan, and DWI) and contrast-enhanced CT of the chest and whole abdomen are performed every three months. Treatment-related toxicity is evaluated using CTCAE v5.0. Cognitive function is assessed every three months using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). Venous blood samples are collected one day before radiotherapy and every three months thereafter to measure white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, liver function, renal function, electrolytes, and coagulation function; stool and urine tests are also performed. The data are analyzed to determine whether whole-brain radiotherapy combined with immunotherapy exacerbates neurological impairment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation Group | – | Drug: PD-1 Inhibitor + Chemotherapy+PCIExtensive-stage small cell lung cancer |
| Control Group | – | Drug: chemotherapy+PCILimited-stage small cell lung cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI).
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI): patients with limited-stage disease achieving complete response (CR) or partial response (PR) after first-line treatment; patients with extensive-stage disease achieving effective tumor control after systemic therapy, with no clear evidence of brain metastasis.
- Age 18-75 years, Karnofsky Performance Status (KPS) score ≥ 70.
- Estimated survival ≥ 6 months, with completion of at least 12 months of follow-up.
- No contraindications to radiotherapy, chemotherapy, or immunotherapy.
- Good compliance with the treatment protocol and follow-up, and provision of informed consent.
Key exclusion criteria (6 listed)
- Patients with brain metastases, cerebral infarction, cerebral hemorrhage, sequelae of traumatic brain injury, or other primary brain diseases (e.g., Alzheimer's disease, multiple sclerosis) confirmed by MRI before enrollment.
- Patients who have previously received brain radiotherapy, brain surgery, or immunotherapy.
- Patients with psychiatric disorders or cognitive impairment (MMSE score < 26) unable to cooperate with follow-up assessments.
- Patients with a history of other malignancies prior to or concurrent with the current treatment.
- Severe cardiac, pulmonary, or renal disease, active autoimmune disease, or uncontrolled active infectious disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 Inhibitor + Chemotherapy+PCIThe study was retrospective and did not use interventional protocols. The recommended first-line treatment for patients with extensive-stage small cell lung cancer is PD-1 inhibitor combined with chemotherapy. Under the condition that brain metastases have been excluded after effective drug therapy, prophylactic cranial irradiation (PCI) may be performed. | Drug | Observation Group |
| chemotherapy+PCIThe study was retrospective and did not use interventional protocols. For patients with limited-stage small cell lung cancer, the recommended first-line treatment is platinum-based cytotoxic chemotherapy, and prophylactic cranial irradiation (PCI) may be administered after achieving a response to drug therapy. | Drug | Control Group |
Primary outcome
Progression-free survival (PFS)
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
the Affiliated Hospital of GuiZhou Medical University
Guiyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer ( SCLC ) and Brain Injury, run by Guizhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.